TEVA PHARMS USA INC FDA Approval ANDA 213256

ANDA 213256

TEVA PHARMS USA INC

FDA Drug Application

Application #213256

Application Sponsors

ANDA 213256TEVA PHARMS USA INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL0.088MG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
002CAPSULE;ORAL0.1MG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM
003CAPSULE;ORAL0.125MG0LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2021-01-06STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

TEVA PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213256
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.088MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.1MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.125MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [originalApprovals] => [{"actionDate":"01\/06\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-01-06
        )

)

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